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Open, Classified

Class IV New Era medical laser device

FDA Recall Z-0440-2021 · Posted None

Recalling FirmInova Lasers LLC
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2020-01-29
Product Quantity8 units

Reason for Recall

The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

Firm Action

Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182604New EraStep UP Skin Laser, LLC · 2018-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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